FDAClass IIAugust 14, 2024

Baxter SIGMA Spectrum Infusion Pump recall

Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2

Why was Baxter SIGMA Spectrum Infusion Pump recalled?

Improperly performed testing prior to release

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: 35700BAX2. Serial Number: 2158913.

Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Recalling firm
Baxter Healthcare Corporation
Quantity
1 unit
Distribution
US Nationwide distribution in the state of Florida.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls